Manufacturing Manager/Supervisor

We are looking for a seasoned Manufacturing Manager/Supervisor with expertise in GMP (Good Manufacturing Practice) environments. The ideal candidate will have over 8 years of relevant experience in overseeing cell culture and downstream processing operations. This person must demonstrate a strong proficiency in cell culture techniques and a track record of ensuring adherence to quality standards. 

RESPONSIBILITIES:

• Oversee GMP manufacturing processes for cell culture-based production
• Ensure strict compliance with established protocols and regulatory standards.
• Lead routine tasks such as media preparation, cell inoculation, bioreactor operation, and harvest operations, ensuring meticulous execution and adherence to quality parameters.
• Spearhead troubleshooting efforts and resolution of process deviations, conducting root cause analyses and implementing corrective measures to optimize manufacturing efficiency.
• Maintain comprehensive documentation of all manufacturing activities in accordance with GMP standards, ensuring the accuracy and completeness of batch records and related documentation.
• Play a pivotal role in technology transfer activities, leveraging expertise in cell culture processes to contribute to process enhancement initiatives.

EXPERIENCE:

• A minimum of 8 years of relevant experience in a managerial or supervisory capacity in the pharmaceutical industry.

Reach out to learn more:
alanah@peoplewithchemistry.com
858-429-6147